Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.

Lead sponsor

Elsan is the lead sponsor of 66 studies on the registry; 33 are open to participants now.

Study arms

• Experimental
  Outpatient procedure

  Procedure: radical prostatectomy

• Active comparator
  Inpatient procedure

  Procedure: radical prostatectomy

Interventions

• Procedureradical prostatectomy

  Robot-assisted

Primary outcomes

1. Early complication of robot-assisted prostatectomy

   The occurrence (yes/no) of at least one early complication of robot-assisted prostatectomy. The early clinical complications expected are : * Bleeding from trocar incision scars or surgical excision scars * Urinary leakage around the catheter * Retention due to bladder catheter clotting * Loss of bladder catheter * Signs of internal haemorrhage (within 24 hours) * Signs of biological deglobulation * Intestinal obstruction syndrome * Signs of urinary fistula * Infectious signs : fever \> 38°, chills * Thromboembolicaccidents * Nosocomial infections * Falls

   Time frame: From the day of surgery to 8 days post-operative

Secondary outcomes

1. Conversion rate from outpatient to full hospitalisation (Outpatient failure rate)

   Patients treated on an outpatient basis for whom full hospitalisation is indicated on the day of surgery, as decided by the medical team.

   Time frame: Day of surgery

2. Rate of cancellation of outpatient treatment by the patient or his private environment

   Patients included in the study refusing outpatient care up to the day of surgery (before or after surgery) for whatever reason

   Time frame: From enrollment to the day of surgery

3. Rate of patients readmitted to hospital, either as emergencies or in the department

   Patients readmitted to hospital (yes/no), emergency or inpatient department

   Time frame: From hospital discharge to 8 days post-operative.

4. Association of each early complication with treatment (outpatient or inpatient)

   Early complication of robot-assisted prostatectomy

   Time frame: From hospitalisation discharge to 8 days post-operative

5. Rate of patients having had at least one complication secondary to surgery

   Patients who had at least one complication secondary to surgery. The expected complications secondary to surgery are: * Admission to emergency care * Re-hospitalization * Occlusions * Healing problems * Perineal hematoma * Urinary infections * Lymphoceles * Thromboembolic accidents * Nosocomial infections

   Time frame: From 8 days to 45 days post-operative

6. Rate of patients with at least one complication secondary to surgery

   Patients who had at least one complication secondary to surgery.

   Time frame: From 45 days to 6 months post-operative

7. Patient's pre-operative stress/anxiety levels

   The participant's stress/anxiety level is assessed at 3 days before surgery using the APAIS (Amsterdam Preoperative Anxiety and Information Scale) questionnaire validated in French (Moerman and al, 1996; Maurice-Szamburski and al, 2013), then with a Numerical Scale of stress/anxiety during preparation for the operating theatre in the care unit and at 2 days post-operative.

   Time frame: 3 days before surgery, day of surgery and 2 days post-operative

8. Patient satisfaction level

   Patient satisfaction is assessed using the overall satisfaction question in the e-SATIS questionnaire ("Overall, how would you rate the quality of your treatment/care in the department by the doctors/surgeons/nurses? Bad/Weak/Average/Good/Excellent) The patient's opinion (yes/no) is evaluated on whether, if the procedure were repeated, the patient would accept it (yes/no) and whether it reassured him/her to go home in the evening /stay in hospital at night after the procedure.

   Time frame: 2 days and 45 days post-operative

9. Duration of surgery

   Duration of surgery 'skin-to-skin' (incision until final stitch complete)

   Time frame: Day of surgery

10. Blood loss

    The level of blood loss is assessed by the quantity of blood recovered in the aspiration jar and the quantity from the drains minus the quantity perfused intraoperatively in ml.

    Time frame: Day of surgery

11. Rate of patients who recovered continence and rate of patients who recovered urinary function after surgery

    Urinary continence is assessed by the response to question 5 of the EPIC-50 (Expanded Prostate Cancer Index Composite) when 0 to 1 pads are used during the day by the patient. Recovery of urinary function was assessed by the difference between the incontinence subscore of the EPIC-50 questionnaire at D45 and the value of the pre-operative score. The incontinence subscore include questions 1, 3, 4, 5 and 6a of the urinary function EPIC-50 questionnaire. The EPIC-50 is a validated questionnaire (Wei and al, 2000) and translated into French (Anota and al, 2016).

    Time frame: Baseline and 45 days post-operative

12. Evolution of urinary continence between 45 days and 6 months post-operatively and evolution of urinary function pre-operatively, at 45 days, at 6 months.

    The evolution of continence and urinary function is established on the basis of the parameters defined previously (see Secondary Outcome Measure 12.)

    Time frame: Baseline and 45 days, 6 months after surgery

13. Recovery of erectile function

    Erectile recovery is assessed using the IIEF-5 (International Index of Erectile Function) questionnaire (Rosen R and al, 1997; Dargis and al, 2013) ; erectile dysfunction is defined by an IIEF-5 score \<10.

    Time frame: Baseline and 6 months post-operative

14. Oncological recurrence and retreatment

    Recurrence is defined by a PSA (Prostate Specific Antigen) level \>0.1ng/ml, the patient's re-treatment (yes/no), the type of re-treatment (hormone therapy / chemotherapy / radiotherapy).

    Time frame: From 45 days to 5 years after surgery

15. Economic and social cost of patient care

    The cost-utility ratio calculated on the basis of : \- The costs of the homogeneous group of patients (GHM) for hospitalisation and the costs of the national care reference system (ENCC) for post-operative management, based on the patient's diary completed up to 6 months after the operation. The following direct medical costs will be estimated from a societal perspective with a time horizon of 6 months: * Medical transport, medical and non-medical consultations in town, complementary examinations and drugs: collected in the CRF of the study from the patient logbook and valued using current tariffs. * The QALY, a unit for measuring life expectancy weighted by health-related quality of life, calculated on the basis of the utility derived from the EQ-5D-5L quality of life questionnaire completed by the patient at D0, D45 and 6 months after surgery.

    Time frame: From hospital discharge to 6 months post-operative

Individual participant data

Plan to share: No